GoingToMeet

Regular audits of vendors are not only required by US law, it is good business. Vendors tend to make changes in their manufacturing process that can unknowingly affect the quality of the product being manufactured. While the vendor's motivation may be harmless, the impact on the unsuspecting customer may be significant. Since the vendor will not tell his customers of the change, the only way to learn of these changes is a vendor audit. Another important use of GMP audits is to self-inspect your own manufacturing facilities to find practices that might result in FD 483 citations in the next inspection of your facility.